GENERAL DESCRIPTION:
Incumbent works in a manufacturing environment with responsibilities that include inspecting, testing, sampling, and sorting products/goods being manufactured, inspections of incoming materials and components, in process subassemblies, and finished products. The QA inspector is required to have technical knowledge of all quality standards and testing equipment.
ESSENTIAL FUNCTIONS:
- QA inspectors reviews protocols, qualification, and validation procedures documented by the organization and follows those procedures. If a manufactured product does not meet quality specifications, the QA inspector investigates and reports production line failures to management.
- Regular and reliable attendance to perform essential function duties, and according to CMP Attendance Policy
- Performs assigned routine tests on incoming materials and components, in process subassemblies, and finished products where results are compared with company quality standards.
- Inspects incoming materials and components, in process subassemblies, and finished products per applicable QC procedures.
- Follows specific procedures to reject non-conforming product.
- Performs detailed inspections when necessary to determine quality of product where limits are not clearly defined.
- Notifies supervisor when inspection data exceeds acceptable limits or when major incidents of poor quality are noted and follows specific procedures to reject non-conforming product.
- Establishes and records results on applicable documents and includes documents in device history record.
- Reviews QC procedures for accuracy and completeness. Notifies the Quality Lab Supervisor when discrepancy is found.
- Performs other tasks or duties as directed by the Quality Lab Supervisor and/or the Manager of Quality Assurance and Regulatory Affairs
- Must be available for overtime when requested
MINIMUM QUALIFICATIONS:
- Must have a High School Diploma or equivalent plus preferred 1 year manufacturing experience in a quality inspector role
- Working knowledge of quality standards, testing/sampling plans and testing equipment or their equivalent in work experience in similar job functions desired.
- Dexterity and preciseness required to operate gauges and testing equipment.
- Ability to set priorities & manage high volume work load; Must be self motivated with flexibility to accommodate changing needs and requirements; Must be dependable and reliable with good attendance record.
- Possess good math, language, reading and writing skills (English)
- Regulated industry experience preferred. Exposure to Medical Devised & cGMP a plus.
- Ability to lift up to 40 lbs. Basic computer knowledge with Data Entry experience in various applications (Word, Excel,& others).
WORKING CONDITIONS:
- Work is primarily performed in a lab setting with frequent exposure to clean room and manufacturing areas, strong orders from solvents and bonding agents and little exposure to noise or heat.
- Physical effort is needed to move, lift and carry product and materials.
- The nature of the work has frequent interruptions; contact with management and production staff
- Requires strong organizational & communication skills.
- May be required to work beyond normal working hours. Hours are subject to change without prior notification.